Diagnosis of Pancreatic Cysts: Endoscopic Ultrasound With Fine Needle Aspiration (EUS/FNA), Direct Visualization, and Confocal Laser-induced Endomicroscopy-A Pilot Study

Pancreatic Cysts Clinical Trial

Official title:

Diagnosis of Pancreatic Cysts: Endoscopic Ultrasound With Fine Needle Aspiration (EUS/FNA), Direct Visualization, and Confocal Laser-induced Endomicroscopy-A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01447238
• Other study ID #: HS2010-7729
• Status: Completed
• Start date: September 15, 2010
• Est. completion date: September 21, 2018

Study information

• Verified date: April 2021
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess the yield of combination modalities in the diagnosis of pancreatic cysts using EUS/FNA, Fiber optics (direct visualization probe), and prototype needle based confocal laser-induced endomicroscopy miniprobe (nCLE).

Description:

Data will be analyzed descriptively to include patient characteristics, procedural variables, and outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: September 21, 2018
• Est. primary completion date: September 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients scheduled for an EUS-FNA procedure of a pancreatic cyst,
• Aged above 18 years
• Granted written informed consent for the study can be included in the study.

Exclusion Criteria:

• Contraindication for undergoing EUS/FNA procedure (such as unwilling or medically unstable patients, patients with severe coagulopathy, patients with poor visualization on EUS for various reasons, etc)
• Pregnant or breastfeeding
• Allergy to fluorescein
• Renal insufficiency

Related Conditions & MeSH terms

• Cysts
• Pancreatic Cyst
• Pancreatic Cysts

Intervention

Device:
• Direct visualization and needle based confocal laser-induced endomicroscopy miniprobe
Patients will undergo the EUS-FNA procedure, as per standard of care, plus an additional direct visualization (fiber optic probe) and nCLE procedure with the prototype probes, which will add 10 minutes maximum to the EUS-FNA procedure. The probes will be positioned against the lining of the pancreatic cyst, and images will be acquired. After imaging, fine needle aspiration of the lesion will be performed, as usual.

Locations

Country	Name	City	State
United States	University of California, Irvine Medical Center	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the yield of combination modalities in the diagnosis of pancreatic cysts using EUS/FNA, Fiber optics (direct visualization probe), and prototype needle based confocal laser-induced endomicroscopy miniprobe (nCLE)	Data will be analyzed descriptively to include patient characteristics, procedural variables, and outcomes.	From the date of imaging until follow up for 6 months to two years.